Vault Health is a digital healthcare company and a leading provider of at-home FDA-approved COVID testing in the United States. Our solution has been deployed to numerous local and state governments, airlines, universities, professional athletic teams, companies and organizations. To date, we've tested millions of people, providing accurate and timely information in the battle against COVID.
Founded in New York City in 2018, Vault Health specializes in Consumer Health, Population Health, and Clinical Trials. Our vision is to deliver seamless and modern healthcare experiences for diagnostics, treatment, and medical care - a digital experience that reduces the need for patients to have to set foot in a doctor’s office. Today, we need your help more than ever to battle the pandemic and build a next generation digital native healthcare company that will transform the world of healthcare.
Vault Health is seeking a Clinical Project Manager (CPM) who will be responsible for the management of all aspects of Clinical Trial Team activities for assigned project(s). The CPM, in concert with the Clinical Program Director, is accountable for achieving successful delivery of the Vault Health clinical team activities at the project level by meeting company and regulatory requirements according to time, quality/scope and budget constraints.
- Proactively manage project level operational aspects of the clinical trials team including management of trial timeline, budget, resources and vendors.
- Provide efficient updates on trial progress to the Clinical Trials Program Manager and/or Director of Clinical Trial Operations, with respect to vendor selection, project plans, trial budget and timeline management, quality standards and risk mitigation.
- Lead sponsor study startup process, including but not limited to conduct of the Trial Kick-off meeting, site selection and finalization of site and vendor Clinical Trial Agreements and budgets.
- Ensure effective project plans are in place and operational for each trial and work proactively with the clinical trial team to set priorities in accordance with applicable project plans, company standard operating procedures (SOPs), ICH/GCP guidelines and regulatory requirements.
- Chair clinical trial team working group and vendor status update meetings and ensure meeting minutes are completed, distributed to team members and filed in a timely manner.
- Monitor the quality of vendor deliverables, address quality issues with the appropriate team member and identify opportunities to improve training, execution and quality control across the clinical team
- Review and approve vendor invoices in collaboration with the Accounting team to ensure investigator payments occur in a timely manner
- Coordinates resources and schedules to achieve desired goals
- Establishes procedures, processes, and milestones while working with management staff to resource projects accordingly.
- Verifies and manages changes in project scope, schedule, and cost.
- Develops and maintains productive working relationships with cross-functional project team and third party service providers/vendors integral to the project delivery.
- Effectively provide support to Clinical Site Manager(s) in the conduct of the trials
- Other duties as assigned
- Bachelor’s Degree in Lifesciences
- 5+ Years Experience in Clinical Project Management experience at a sponsor or CRO company is preferred for CPM
- Excellent verbal and written communication skills
- Must have a thorough knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research and data management methods.
Vault is a high growth, fast paced organization. The ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically (and potentially internationally) is required, it is anticipated that this will be less than 15 % of work time.
Who You Are:
- Dynamic, gregarious individual with a constant focus on the patient experience
- Background in the life sciences / healthcare / clinical trials space with an understanding of the space
- High comfort level with ambiguity; adapting to change, learning, and growth
- Proactive, forward-looking, flexible and creative team player who enjoys collaborating and getting things done without an ego
- Open to receiving and giving feedback
- Highly effective written and verbal communication skills
- Organized, with a strong ability to multitask and shift priorities when needed
- Entrepreneurial approach to responsibilities
Vault Health is an equal opportunity employer. All applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, national origin, age, disability, or veteran status.